What this trial studies
Obesity represents a serious global health issue with significant consequences, including an increased risk of chronic diseases. Statistics indicate a growing trend of obesity, highlighting the need to seek methods that improve fat tissue metabolism and reduce obesity-related complications. Previous research on animals has shown that betaine, a substance engaged in one-carbon metabolism, may enhance fat oxidation and lower adipose tissue. Therefore, the aim of the research will be to assess the impact of 8-week betaine supplementation on body composition and lipid metabolism markers, as well as expression of genes related to lipid metabolism, in a group of adult women with abdominal obesity.
Conditions in scope
- Overweight and Obesity
Interventions
- Betaine (Dietary Supplement) — Betaine supplemented for 8 weeks
- Placebo (Dietary Supplement) — Placebo supplementation for 8 weeks
Who can join
Women only · Ages 18 Years to 45 Years · Accepts healthy volunteers.
Inclusion criteria
- females
- age: 18-45 years
- pre-menopausal
- overweight or obese: BMI \>25 kg/m2
- waist circumference \> 80 cm
Exclusion criteria
- males
- age \<18 or \>45 years
- perimenopausal or postmenopausal
- BMI \< 25 kg/m2
- waist circumference \< 80 cm
- betaine administration for 3 months prior to study
- pregnant or breastfeeding
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Poznan | Poznan University of Life Sciences | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: N/A
- Start date: 2024-09-01
- Primary completion: 2025-06-30
- Last update posted: 2025-11-24
- First posted: 2024-04-03
Sponsor & contact
Lead sponsor: Poznan University of Life Sciences (Other)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Body composition (8 weeks, three measurements: at week 0, 4 and 8)
Body composition will include percent body fat and lean body mass measured with air displacement plethysmography - Body mass (8 weeks, three measurements: at week 0, 4 and 8)
Measured in kg - Waist and hips circumference (8 weeks, three measurements: at week 0, 4 and 8)
Measured in cm - Lipid profile (8 weeks, two measurements: at week 0 and 8)
Total cholesterol, Triacylglycerols, LDL-cholesterol, HDL-cholesterol - Gene expression (8 weeks, two measurements: at week 0 and 8)
Included genes relate to lipid metabolism in adipose tissue: PPARG, CD36, FABP4, UCP1, PPARGC1A, LEP, ADIPOQ, INSR, IRS1, DGAT2, SREBF1, ELOVL5 , FADS3, FASN
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT06344377 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.